Sperm CapacitationNCT00731159
Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment
An observational study of Sperm Capacitation, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sperm Capacitation
- What is being tested?
- sperm capacitation and biologic
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients requiring IVF within the "routine" work of an IVF Unit
Who may be able to join
- Patients requiring IVF within the "routine" work of an IVF Unit
- normo-responding woman
- non ICSI cycles
Who cannot join
- Patients undergoing ICSI only cycle
- Low responders-less than 8 oocytes
- Male patients with low semen volume
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh MC
Beer Yaacov, Zerifin, 70300
arieh raziel, prof, 97289779005, araziel@asaf.health.gov.il
raphael ron-el, prof, 97289779005, rronel@asaf.health.gov.il
About this study
Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments
Read the detailed description
Capacitation is a physiologic process in which the sperm acquire the potential to fertilize oocytes. Capacitation can be measured, but the available technics are expensive, inaccurate and complex. A new method to evaluate sperm capacitation was developed in Bar Ilan University, Israel. We intend to measure the capacitation of semen that is used for fertilizing human oocytes in patients treated at the IVF unit at Assaf Harofeh Medical Center.By this, to evaluate the potential of the new method to predict human oocyte fertilization.If the method will be found valuable, it will enable to develop new drugs/methods that may improve sperm capacitation and by this to improve oocyte fertilization leading to more embryos, pregnancies and deliveries.
- Conditions
- Sperm Capacitation
- Being tested
- sperm capacitation, biologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sperm capacitationBiological
sperm capacitation measured at Bar Ilan University
biologicOther
Also called sperm capacitation
sperm synthesis of G-actine to F-actine
sperm capacitationOther
Also called sperm synthesis of G-actine to F-actine
sperm synthesis of G-actine to F-actine
| Study group | Role | What they receive |
|---|---|---|
| A | Sperm capacitation:
Sperm capacitation is measured in a sample of the same ejaculated sperm unit given for fertilizing human oocytes in an IVF treatment cycle Receives: Biological: sperm capacitation; Other: biologic; Other: sperm capacitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate of human oocytes in thr "routine" IVF Laboratory work
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm CapacitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731159
- Sponsor's protocol ID
- 54/08
- Status last verified
- Jul 2008
- First submitted
- 7 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment
- ClinicalTrials.gov ID
- NCT00731159
- Acronym / sponsor ID
- 54/08
- Conditions
- Sperm Capacitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments
Detailed description
Capacitation is a physiologic process in which the sperm acquire the potential to fertilize oocytes. Capacitation can be measured, but the available technics are expensive, inaccurate and complex. A new method to evaluate sperm capacitation was developed in Bar Ilan University, Israel. We intend to measure the capacitation of semen that is used for fertilizing human oocytes in patients treated at the IVF unit at Assaf Harofeh Medical Center.By this, to evaluate the potential of the new method to predict human oocyte fertilization.If the method will be found valuable, it will enable to develop new drugs/methods that may improve sperm capacitation and by this to improve oocyte fertilization leading to more embryos, pregnancies and deliveries.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Biological: sperm capacitation, Other: biologic, Other: sperm capacitationSperm capacitation: Sperm capacitation is measured in a sample of the same ejaculated sperm unit given for fertilizing human oocytes in an IVF treatment cycle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients requiring IVF within the "routine" work of an IVF Unit
Key inclusion criteria (3 listed)
- Patients requiring IVF within the "routine" work of an IVF Unit
- normo-responding woman
- non ICSI cycles
Key exclusion criteria (3 listed)
- Patients undergoing ICSI only cycle
- Low responders-less than 8 oocytes
- Male patients with low semen volume
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sperm capacitationsperm capacitation measured at Bar Ilan University | Biological | A |
| biologicAlso: sperm capacitationsperm synthesis of G-actine to F-actine | Other | A |
| sperm capacitationAlso: sperm synthesis of G-actine to F-actinesperm synthesis of G-actine to F-actine | Other | A |
Primary outcome
Fertilization rate of human oocytes in thr "routine" IVF Laboratory work
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
Related trials for Sperm Capacitation
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm Capacitation, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact arieh raziel, prof (97289779005, araziel@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate of human oocytes in thr "routine" IVF Laboratory work (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.